Cannabis Gummy for the Improvement of Sleep and Quality of Life in Patients With Cancer, Pillow Trial

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheodore Brasky PhD

About this trial

This clinical trial tests how well a cannabis gummy works in improving sleep and quality of life in patients with cancer. Many people with cancer (about 60%) have trouble sleeping, which can lower their quality of life. Sleep disturbance is defined as difficulty initiating or maintaining sleep, waking up earlier than desired and being unable to fall back to sleep, and excessive daytime sleepiness. In adults with cancer, sleep disturbance may be caused by multiple, often co-occurring factors including diagnosis, type, and stage of cancer, treatment regimen, physical complaints (e.g., pain), and psychological distress. Some patients use cannabis to help with sleep, but its effects are not well understood. Cannabis, which some people call marijuana, refers to the dried leaves, flowers, stems, and seeds of the cannabis sativa L plant. The plant contains at least 125 different cannabinoids, including delta-9 tetrahydrocannabinol (THC). Delta-9 THC is the most abundant form of THC in the cannabis plant. It has intoxicating effects, meaning it can temporarily alter a person's mood, thoughts, and perceptions (a "high"). This study will help researchers learn how cannabis affects sleep and quality of life compared to usual care.

Eligibility criteria

Qualifiers

New patients in the OSUCCC's Palliative Care clinics who have histologically or cytologically confirmed malignancy of any anatomic site. This applies to either newly diagnosed cancer or those with preexisting malignancy receiving treatment

Reported sleep disturbance (≥ 4) in the Edmonton Symptom Assessment System, the clinic's symptom screener administered at every visit

Patients with active cancers and are under any line of treatment or have received cancer treatment in the past 6 months (please see notable exceptions in the

Disqualifiers

patients taking checkpoint inhibitors and investigational agents will not be eligible)

If patients are currently receiving cancer therapy, they must have been taking their current anti-cancer intervention/ therapy regimen for at least one month prior to enrollment (to ensure no safety or toxicity issues with study drug initiation)

Age ≥ 18 years

English speaking with the ability to understand and the willingness to sign a written informed consent document

Trial design

Treatments tested in this trial

  • Actigraphy
  • Best Practice
  • Biospecimen Collection
  • Ecological Momentary Assessment
  • Questionnaire Administration
  • Single Agent Therapy

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Theodore Brasky PhD

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution